Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT)

Deep Vein Thrombosis Clinical Trial

— SELECT  

Official title:

Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157677
• Other study ID #: CTMG-2005-SELECT
• Secondary ID: Grant Number: NA
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: October 25, 2011
• Start date: October 2004
• Est. completion date: June 2010

Study information

• Verified date: October 2011
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two diagnostic interventions to improve the way D-dimer blood testing (MDA D-dimer) is used to diagnose first time symptomatic deep vein thrombosis.

Description:

• Limiting use of D-dimer testing to outpatients with a Low or Moderate clinical pretest probability (C-PTP)for deep vein thrombosis AND using a D-dimer level of < 1.0 µg FEU/mL to exclude deep vein thrombosis in those with a Low C-PTP, and a D-dimer level of < 0.5 µg FEU/mL to exclude deep vein thrombosis in those with a Moderate C-PTP, is as safe and a more efficient way to diagnose DVT than:

• Performing D-dimer testing in all patients with suspected deep vein thrombosis with use of a single D-dimer value of < 0.5 µg FEU/mL to exclude thrombosis (current practice).

All randomized patients, including those who are treated for deep vein thrombosis after initial testing, will be followed for a period of 3 months to monitor for signs and symptoms suggestive of deep vein thrombosis, pulmonary embolism, bleeds and death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1727
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and older

• Presenting with symptoms compatible with clinically suspected deep vein thrombosis

Exclusion Criteria:

• Treatment with full dose anticoagulation for 24 hours or more.

• Other test for deep vein thrombosis already performed.

• Ongoing need for therapeutic anticoagulant therapy.

• Life expectancy less than 3 months.

• Absence of acute symptoms within 7 days of presentation.

• Presenting with symptoms of pulmonary embolism.

• Previous confirmed episode of deep vein thrombosis or pulmonary embolism.

• Current pregnancy.

• Geographic inaccessibility which precludes follow-up.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• D-dimer testing
Uniform D-dimer use
• D-dimer testing
Selective D-Dimer use

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences, General	Hamilton	Ontario
Canada	Hamilton Health Sciences, Henderson	Hamilton	Ontario
Canada	Hamilton Health Sciences, McMaster	Hamilton	Ontario
Canada	St. Joseph's Health Care Centre	Hamilton	Ontario
Canada	SMBD Jewish General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objectively confirmed proximal deep vein thrombosis or pulmonary embolism during 3 months of follow-up in patients who are not diagnosed with deep vein thrombosis during diagnostic testing and are not anticoagulated		3 Months	Yes
Secondary	bleeding		3 Months	Yes
Secondary	healthcare utilization		3 Months	No
Secondary	cost-effectiveness		3 Months	No